Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application claims priority to the applications, JP2021-081310 and PCT/JP2022/020078, with effective filing dates of 12 May 2021 and 12 May 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Amendment filed, 6 May 2026, wherein Applicant amended claims 10 and 12-13, canceled claim 11, and added new claims 14-24.
Claims 10 and 12-24 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 29 May 2026 and the references cited therein have been considered, unless indicated otherwise.
Rejections: Withdrawn
Claim Rejections – 35 U.S.C. § 112
1. Claim 11 was rejected for being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 was canceled. The rejection of claim 11 has been withdrawn.
Claim Rejections – 35 U.S.C. § 102
2. Claims 10-13 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anson (J. Nutrition, 2011, 141(I)¸137-143; of record; see PTO-892 mailed 6 Feb 2026) as evidenced by Huang (Scientific Reports¸2019, 9(15585), 1-8; of record; see PTO-892 mailed 6 Feb 2026) and Nishibe (Molecules¸2021, 26(2362), 1-21; of record; see PTO-892 mailed 6 Feb 2026).
Applicant amended claims 10 and 12-13 to specify preparing a composition by compounding, the composition containing a pharmaceutically acceptable carrier and an effective amount of an anti-metabolic syndrome agent. Claim 11 was canceled. Applicant’s amendment, see pages 2-3, with respect to claims 10 and 12-13 has been fully considered. The 102(a)(1) rejection of claims 10 and 12-13 has been withdrawn.
Claim Rejections – Non-statutory Double Patenting
3. Claims 10-11 were rejected on the ground of non-statutory double patenting over claim 6 of copending Application No. 17/764,666. Claim 11 was canceled. The terminal disclaimer filed on 5 May 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 17/764,666 has been reviewed and is accepted. The terminal disclaimer has been recorded. Accordingly, the rejection of claim 10 on the ground of non-statutory double patenting has been withdrawn.
Rejections: Maintained/New
Claim Rejections – 35 U.S.C. § 103
4. (Maintained) Claims 10-13 were rejected as being unpatentable under 35 U.S.C. 103 over Anson (J. Nutrition, 2011, 141(I)¸137-143; of record; see PTO-892 mailed 6 Feb 2026) in view of Nishitani (JP 2016-079186, published 16 May 2016, see IDS filed 14 Feb 2024).
Applicant’s amendment and arguments, see pages 2-3 and 10-17, with respect to the rejection of claims 10-13 have been fully considered but they are not persuasive. Claim 11 was canceled.
Applicant asserts that Anson does not contemplate preparing or administering as required in independent claim 10 and that none of Huang, Nishibe, or Nishitani cure or rectify the deficiencies in the teachings of Anson. Applicant states that Anson does not teach method steps of “preparing” and “administering” and therefore cannot contemplate or suggest either step of preparing a composition by compounding, the composition containing a pharmaceutically acceptable carrier and an effective amount of an anti-metabolic syndrome agent or administering the composition containing the effective amount of the anti-metabolic syndrome agent to the patient as presently claimed. Applicant further states that Applicant’s preparing step requires preparing a composition outside the body or ex vivo. Applicant additionally states that Nishitani differs via methoxy, which has a significant and multifaceted impact on the pharmacology of organic compound by altering the pharmacodynamic/pharmacokinetic properties and cites Chiodi (Eur. J. Med. Chem., 2024, 273(116364), 1-94; As Applicant did not provide a copy, see PTO-892 accompanying this Office Action).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s arguments regarding Nishitani in view of Chiodi, Chiodi provides evidence for the inclusion of a methoxy for beneficial pharmacokinetics/pharmacodynamics. However, Chiodi does not provide objective evidence for the specific compound, dihydroferulic acid, and what is observed or different for the pharmacokinetics/pharmacodynamics. Accordingly, Applicant’s arguments do not remedy the 35 U.S.C. 103 rejection.
Accordingly, the rejection of claims 10 and 12-13 as being unpatentable over Anson in view of Nishitani is maintained.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
4. (New) Claims 14-24 are rejected as being unpatentable under 35 U.S.C. 103 over Anson (J. Nutrition, 2011, 141(I)¸137-143; of record; see PTO-892 mailed 6 Feb 2026) in view of Nishitani (JP 2016-079186, published 16 May 2016, see IDS filed 14 Feb 2024) as evidenced by Huang (Scientific Reports¸2019, 9(15585), 1-8; of record; see PTO-892 mailed 6 Feb 2026), Nishibe (Molecules¸2021, 26(2362), 1-21; of record; see PTO-892 mailed 6 Feb 2026), and Cleveland Clinic (page 2, bullet points 1-3; “Metabolic Syndrome,” Cleveland Clinic, 13 Sept 2023, <my.clevelandclinic.org/health/diseases/10783- metabolic-syndrome>, accessed 14 Jan 2026; of record, see PTO-892 mailed 6 Feb 2026).
Anson teaches bioprocessed bran increases bioavailability of phenolic acids in men and
has activity against metabolic syndrome (abstract, page 141, column 1, paragraph 4; page 141,
column 2, paragraph 1; Table 3, page 141). Anson further teaches that whole grain consumption is linked to lower risk of metabolic syndrome, which is normally associated with a low-grade chronic inflammation and that bran is rich in phenolic acids (abstract). Additionally, Anson specifies preparation of bioprocessed bread for investigating effect of bioprocessing of bran in whole wheat bread on bioavailability of phenolic compounds, plasma antioxidant capacity, and anti-inflammatory potential (page 138, paragraphs 2, 4, and 5). Anson specifies phenolic compounds, phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid, and shows that the bioprocessed bread led to lower pro- to anti-inflammatory cytokine ratios than the control bread (Table 3, page 141; page 141, column 1, paragraph 2).
Regarding claim 14, Anson fails to teach the effective amount of the anti-metabolic syndrome agent is about 1 to 1000 mg daily.
Nishitani teaches pharmaceutical compositions and methods of preventing or ameliorating insulin resistance (metabolic syndrome as defined by Cleveland Clinic; see claim interpretation) via coffee polyphenols (akin to compounds 1-3):
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([0001], [0004], [0005], [0008], [0052], and [0053]). Nishitani further teaches that the compounds therein are administered in the range of 1 to 1000 mg daily ([0109]).
It would have been prima facie obvious to one or ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the pharmaceutical composition for ameliorating or preventing insulin resistance as taught by Anson via the coffee polyphenols of Nishitani to develop a method of preventing or ameliorating via administration of compounds 1-3:
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, to arrive at instant claim 12. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Anson teaches bioprocessed bran increases bioavailability of phenolic acids in men and has activity against metabolic syndrome,
-Anson teaches that whole grain consumption is linked to lower risk of metabolic syndrome, which is normally associated with a low-grade chronic inflammation and that bran is rich in phenolic acids,
-Anson teaches preparation of bioprocessed bread for investigating effect of bioprocessing of bran in whole wheat bread on bioavailability of phenolic compounds, plasma antioxidant capacity, and anti-inflammatory potential,
-Anson teaches phenolic compounds, phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid, and shows that the bioprocessed bread led to lower pro- to anti-inflammatory cytokine ratios than the control bread,
-Nishitani teaches dihydroferulic acid,
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, which is similar in structure to compounds 1-3, and inhibits cAMP and DPP IV ([0001], [0004], [0005], [0008], [0052],
-Nishitani teaches oral compositions useful in treatment of insulin resistance ([0005], [0053]), and
-Nishitani teaches that the compounds therein are administered in the range of 1 to 1000 mg daily ([0109]).
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of preventing or ameliorating metabolic syndrome via administration of an oral composition of anti-metabolic agent: compounds 1-3, which are administered in the range of 1 to 1000 mg daily.
Regarding claim 15, Nishitani teaches a tablet ([0073]; [0109]). Anson teaches Compound 1: 3(3,4-dihydroxyphenyl)-propionic acid (Table 3, page 141; page 141, column 1, paragraph 2). Thus, the combination of Nishitani and Anson teaches a tablet of Compound 1.
Regarding claim 16, Nishitani teaches a capsule ([0109]). Anson teaches Compound 3: phenylpropanoic acid (Table 3, page 141; page 141, column 1, paragraph 2). Thus, the combination of Nishitani and Anson teaches a capsule of Compound 3.
Regarding claim 17, Nishitani teaches a liquid ([0073]). Anson teaches Compound 2: 4-hydroxyphenyl propionic acid (Table 3, page 141; page 141, column 1, paragraph 2). Thus, the combination of Nishitani and Anson teaches a liquid of Compound 2.
Regarding claim 18, Nishitani teaches pharmaceutical compositions and methods of preventing or ameliorating insulin resistance (metabolic syndrome as defined by Cleveland Clinic; see claim interpretation) via coffee polyphenols (akin to compounds 1-3):
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([0001], [0004], [0005], [0008], [0052], and [0053]). Nishitani teaches oral administration of the compounds therein ([0076]; [0107]). Anson specifies phenolic compounds, phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid, and shows that the bioprocessed bread led to lower pro- to anti-inflammatory cytokine ratios than the control bread (Table 3, page 141; page 141, column 1, paragraph 2). Anson teaches oral administration of phenolic acids to men for metabolic syndrome (abstract, page 141, column 1, paragraph 4; page 141, column 2, paragraph 1; Table 3, page 141).
Regarding claim 19, Nishitani further teaches that the compounds therein are administered in the range of 1 to 1000 mg daily ([0109]).
Regarding claim 20, Nishitani teaches a tablet administered orally ([0073]; [0107]; [0109]). Anson teaches Compound 1: 3(3,4-dihydroxyphenyl)-propionic acid (Table 3, page 141; page 141, column 1, paragraph 2). Thus, the combination of Nishitani and Anson teaches a tablet of Compound 1.
Regarding claim 21, Nishitani teaches a capsule administered orally ([0107]; [0109]). Anson teaches Compound 3: phenylpropanoic acid (Table 3, page 141; page 141, column 1, paragraph 2). Thus, the combination of Nishitani and Anson teaches a capsule of Compound 3.
Regarding claim 22, Nishitani teaches a liquid administered orally ([0073]; [0107]). Anson teaches Compound 2: 4-hydroxyphenyl propionic acid (Table 3, page 141; page 141, column 1, paragraph 2). Thus, the combination of Nishitani and Anson teaches a liquid of Compound 2.
Regarding claim 23, Regarding claim 18, Nishitani teaches pharmaceutical compositions and methods of preventing or ameliorating insulin resistance (metabolic syndrome as defined by Cleveland Clinic; see claim interpretation) via coffee polyphenols (akin to compounds 1-3):
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([0001], [0004], [0005], [0008], [0052], and [0053]). Nishitani teaches transdermal administration of the compounds therein ([0076]; [0107]). Anson specifies phenolic compounds, phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid, and shows that the bioprocessed bread led to lower pro- to anti-inflammatory cytokine ratios than the control bread (Table 3, page 141; page 141, column 1, paragraph 2). Anson teaches oral administration of phenolic acids to men for metabolic syndrome (abstract, page 141, column 1, paragraph 4; page 141, column 2, paragraph 1; Table 3, page 141).
Regarding claim 24, Nishitani teaches a skin cosmetic and a hair cosmetic ([0073]).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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